Multicenter Study of HGT-1110 Administered Intrathecally in Children With Metachromatic Leukodystrophy (MLD)

Exclusion Criteria

• •Patients will be excluded from the study if there is evidence or history of any of the following criteria at screening:
• •For Cohorts 1-4:
• •1. History of hematopoietic stem cell transplantation (HSCT).
• •2. The patient has any known or suspected hypersensitivity to anesthesia or is thought to be at an unacceptably high risk for anesthesia due to airway compromise or other conditions.
• •3. Any other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the trial.
• •4. The patient is enrolled in another clinical study that involves the use of any investigational product (drug or device) other than HGT-1110 or the IDDD used in this study within 30 days prior to study enrollment or at any time during the study.
• •5. The patient is pregnant or breastfeeding.
• •6. The patient has a condition that is contraindicated as described in the SOPH-A-PORT
• •Mini S IDDD Instructions for Use (IFU), including:
• •1. The patient has had, or may have, an allergic reaction to the materials of construction of the SOPH-A-PORT Mini S device.
• •2. The patient's body size is too small to support the size of the SOPH-A-PORT Mini S Access Port, as judged by the Investigator.
• •3. The patient has a known or suspected local or general infection.
• •4. The patient is at risk of abnormal bleeding due to a medical condition or therapy.
• •5. The patient has one or more spinal abnormalities that could complicate safe implantation or fixation.
• •6. The patient has a functioning CSF shunt device.
• •7. The patient has shown an intolerance to an implanted device.